VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
FDA 510(k) clearance K023381 · decided 2003-03-31
Clearance details
- K-number
- K023381
- Device name
- VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
- Applicant
- Gish Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-08
- Decision date
- 2003-03-31
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) recall (Z-0519-06) | Gish Biomedical Inc | 2006-02-14 |
| Vision Hollow Fiber Oxygenator with GBS Coating recall (Z-0730-04) | Gish Biomedical Inc | 2004-07-20 |